Device Classification Name |
acid, uric, uricase (u.v.)
|
510(k) Number |
K873358 |
Device Name |
GEMENI URIC ACID U.V. |
Applicant |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
7101 RIVERWOOD DR. |
COLUMBIA,
MD
21046
|
|
Applicant Contact |
LABREC, PHD |
Correspondent |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
7101 RIVERWOOD DR. |
COLUMBIA,
MD
21046
|
|
Correspondent Contact |
LABREC, PHD |
Regulation Number | 862.1775
|
Classification Product Code |
|
Date Received | 08/21/1987 |
Decision Date | 09/11/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|